| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K201620 |
01/29/2021 |
Luna« G3 BPAP 25A |
3B Medical, Inc. |
Yasser Estafanous |
| K211244 |
11/10/2021 |
VSP« Orthopedics System |
3D Systems |
Ben Johnson |
| K212237 |
11/29/2021 |
3D-Cut |
3D-Side SA |
Laurent Paul |
| K210943 |
11/22/2021 |
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) |
Abbott Diabetes Care Inc. |
Ono Bacani |
| K203248 |
11/23/2021 |
Albumin BCG2 |
Abbott Ireland Diagnostics Division |
Suzanne Cheang |
| K201778 |
01/08/2021 |
i-STAT TBI Plasma cartridge with the i-STAT Alinity System |
Abbott Laboratories |
Brian Ma |
| K213364 |
11/11/2021 |
EnSite X EP System |
Abbott Medical |
Tabitha Payne |
| K203373 |
01/22/2021 |
Advanced Research Medical Trident SI Screw System |
Advanced Research Medical, LLC |
John D. Siegel |
| K203531 |
01/29/2021 |
XYPAN Expandable Lumbar Cage System |
Aegis Spine, Inc. |
Woo Joong Kwon |
| K203189 |
01/21/2021 |
AEROCURE-MD |
Aerobiotix, Inc. |
David Kirschman |
| K202391 |
01/21/2021 |
DIR 800 |
Aesculap, Inc. |
Kathy A. Racosky |
| K212275 |
11/18/2021 |
Dermalux Flex MD |
Aesthetic Technology Ltd. |
Dale Needham |
| K212659 |
11/10/2021 |
More-Cell-System |
Agency for Medical Innovations GmbH |
Martin Hohlrieder |
| K213469 |
11/18/2021 |
VALORY |
Agfa N.V. |
Wim Govaerts |
| K200491 |
01/05/2021 |
Bfix Orthopedic External Fixator Systems |
Aike (Shanghai) Medical Instrument Co., Ltd. |
Gu Hongying |
| K203209 |
01/15/2021 |
AirPhysio Positive Expiratory Pressure (PEP) Device |
AirPhysio Pty Ltd |
Paul OÆBrien |
| K193497 |
01/05/2021 |
Fixone Biocomposite Interference Screw |
AJU Pharm Co., Ltd. |
Kim Joong Kil |
| K211668 |
11/30/2021 |
KardiaMobile Card |
AliveCor, Inc. |
Saket Bhatt |
| K210499 |
11/01/2021 |
Alpha Dent Implants Dental Implants System |
Alpha Dent Implants GmbH |
Simha Sibony |
| K200922 |
01/26/2021 |
Altus Spine HA Pedicle Screw System |
Altus Partners, LLC |
Mark Melton |
| DEN210006 |
11/13/2021 |
Hemolung Respiratory Assist System |
ALung Technologies, Inc. |
Joe Argyros |
| K211983 |
11/24/2021 |
AMRA Profiler |
AMRA Medical AB |
Eric Converse |
| K202791 |
01/05/2021 |
iHealth Clinical Digital Thermometer |
Andon Health Co., Ltd. |
Liu Yi |
| K211696 |
11/30/2021 |
Disposable Surgical Face Mask |
Anhui Cleanpro Pharmpack Co., Ltd. |
Chong Xiuming |
| K212551 |
11/05/2021 |
Nitrile Examination Gloves |
Anhui Fine Glove Medical Technology Co., Ltd |
Guanghao Liu |
| K211956 |
11/23/2021 |
039 Surgical Face Mask |
AOK Tooling Limited |
Francis Nithyananthan |
| K203010 |
01/22/2021 |
Platinum dRF Imaging System |
Apelem-DMS Group |
Samuel Sancerni |
| K200021 |
01/06/2021 |
Applied Medical Anoscope |
Applied Medical Resources |
Frans VandenBroek |
| DEN210014 |
11/16/2021 |
EaseVRx |
AppliedVR, Inc. |
Jafar Shenasa |
| K202880 |
01/04/2021 |
J-Plasma Precise FLEX Handpiece |
Apyx Medical Corporation (formerly Bovie Medical Corporation |
Lauren Tiller |
| K200963 |
01/05/2021 |
Halo Single-Loop Microsnare Kit |
Argon Medical Devices, Inc. |
Ana Jimenez-Hughes |
| K202141 |
01/15/2021 |
Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set |
Argon Medical Devices, Inc. |
Amy Clendening-Wheeler |
| K212415 |
11/17/2021 |
Arthrex Modular Glenoid System-Titanium Glenosphere |
Arthrex Inc. |
David L. Rogers |
| K213213 |
11/19/2021 |
Arthrex Vortex Threaded Bone Marrow Recovery Needle |
Arthrex Inc. |
Nick Moore |
| K201872 |
01/05/2021 |
NeutrArt |
Asset Medikal Tasarim AS. |
Ebru Sirali |
| K202495 |
01/06/2021 |
SIRION Lateral Lumbar Interbody Fusion |
Astura Medical, LLC |
Parker Kelch |
| K200163 |
01/19/2021 |
Ava Fertility Tracker |
Ava AG |
Blathnaid Feldman |
| K212047 |
11/16/2021 |
Pantheris System |
Avinger, Inc. |
Thomas Lawson |
| K211538 |
11/17/2021 |
Protect X Level 3 Isolation Gown |
AZAC Group |
Yen Ping Shan |
| K210350 |
11/18/2021 |
Gemini 2 810+980 Soft Tissue Laser |
Azena Medical, LLC |
Lindsay Tilton |
| K212912 |
11/04/2021 |
OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System |
b-ONE ORTHO, Corp |
Allison Gecik |
| K202843 |
01/12/2021 |
Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) |
B.J.ZH.F.Panther Medical Equipment Co., Ltd |
Jiahui Li |
| K202366 |
01/29/2021 |
MAGIC Infusion Catheter |
Balt USA, LLC |
Corina Pierson |
| K211649 |
11/23/2021 |
PCEA Syringe Set |
Baxter Healthcare Corporation |
Jeffrey E Thompson |
| K203453 |
01/25/2021 |
BD Hypodermic Syringe |
Becton Dickinson and Company |
Charlton Foo |
| K212015 |
11/19/2021 |
BD Nano 2nd Gen Pen Needle |
Becton Dickinson and Company |
Charlton Foo |
| K191964 |
11/03/2021 |
BD Kiestra IdentifA |
Becton, Dickinson and Company |
Janine Spafford |
| K201700 |
01/13/2021 |
BEGO Semados« RS/RSX Implant System |
BEGO Implant Systems GmbH & Co. KG |
Bertrand Lecointe |
| K202844 |
01/06/2021 |
Medical Surgical Gowns |
Beijing Biosis Healing Biological Technology Co., Ltd |
Ting Jiang |
| K211754 |
11/15/2021 |
Vital Signs Monitor |
Beijing Choice Electronic Technology Co., Ltd. |
Haiying Zhao |
| K202371 |
11/08/2021 |
Highspeed Airturbine Handpiece |
Beijing Dongbo Dental Handpiece Co., Ltd. |
Chao Hao |
| K212978 |
11/10/2021 |
Diode laser therapy system |
BEIJING UNT Technology Co., Ltd |
Qianwen Sheng |
| K202326 |
11/09/2021 |
BESPA Charcot System |
Bespa Global, LLC |
Lisa Viele |
| K210253 |
11/05/2021 |
Best Glove-Latex Powder Free Examination Glove |
Bestsafe Glove CO., LTD. |
Piyawat Chirasakulkarun |
| K201219 |
01/19/2021 |
Biocore9 Femoral Head Resurfacing Component |
BioCore9 LLC |
Stan Matlak |
| K211079 |
11/01/2021 |
BioFire COVID-19 Test 2 |
BioFire Defense, LLC |
Cynthia Phillips |
| K202934 |
01/26/2021 |
Blood Pressure Monitor |
Bioland Technology Ltd. |
Yiqing Feng |
| K210757 |
11/12/2021 |
ETEST Fosfomycin (FO) (0.032-512 ╡g/mL) |
bioMerieux SA |
Marine Taravant |
| K211729 |
11/04/2021 |
Comprehensive« Convertible Glenoid - Vivacit-E Liner |
Biomet Manufacturing Corp. |
Patricia Sandborn Beres |
| K203474 |
01/28/2021 |
Biomet Microfixation RibFix Advantage System |
Biomet Micofixation |
Lauren Jasper |
| K203397 |
01/11/2021 |
Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm |
Biopsybell s.r.l. |
Carlo Ricca Prandi Bellini |
| K212068 |
11/08/2021 |
Biotech Dental Kits |
Biotech Dental, SAS |
Delphine Mercier |
| K212765 |
11/15/2021 |
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank |
Bloomden Bioceramics (HuNan) Co., Ltd |
Shengyong Liao |
| K212537 |
11/03/2021 |
REAL INTELLIGENCE CORI (CORI) |
Blue Belt Technologies, Inc. |
Sarah Plittman |
| K202278 |
01/08/2021 |
OBS Anchorage Screw, Biokey Anchorage Screw |
Bomei Co, Ltd. |
Steven Pan |
| K211080 |
11/19/2021 |
EkoSonic Endovascular Device |
Boston Scientific |
Joshua Kim |
| K211960 |
11/22/2021 |
Agile Esophageal OTW Stent System |
Boston Scientific Corporation |
Inderdeep Tiwana |
| K210989 |
11/12/2021 |
Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System |
Brainlab AG |
Chiara Cunico |
| K201752 |
01/29/2021 |
Disposable Pre-calibrated Suction |
Brainlab AG |
Chiara Cunico |
| K211544 |
11/03/2021 |
Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization |
Brainlab AG |
Chiara Cunico |
| K202847 |
01/15/2021 |
AccuBrain |
BrainNow Medical Technology Limited |
Junbing Huang |
| K193586 |
01/27/2021 |
Vivo 45 LS |
Breas Medical AB |
Ari Sobel |
| K202792 |
01/22/2021 |
BRIUS Clear Aligners |
Brius Technologies, Inc |
Kate Garrett |
| K200702 |
01/14/2021 |
EasyPath RF Introducer Sheath |
Broncus Medical, Inc |
Robin Bush |
| K200382 |
01/06/2021 |
BTL-703-2 |
BTL |
David Chmel |
| K202199 |
01/26/2021 |
BTL-899ST |
BTL |
David Chmel |
| K210598 |
11/02/2021 |
Pediatric Nasogastric Feeding Tubes - Single ENFit Port |
CAIR LGL |
Irving L. Wiesen |
| K211975 |
11/10/2021 |
Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System |
Caldera Medical, Inc. |
Vicki Gail |
| K203849 |
01/26/2021 |
General Radiography CXDI-CS01 |
CANON INC. |
Akira Hirai |
| K201836 |
01/12/2021 |
Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i |
Canon Medical Systems Corporation |
Paul Biggins |
| K202767 |
01/15/2021 |
Vantage Orian 1.5T, MRT-1550, V6.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K203683 |
01/15/2021 |
CarboClear Lumbar Cage System |
CarboFix Orthpedics Ltd. |
Hila Wachsler-Avrahami |
| K211765 |
11/23/2021 |
Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown |
Cardinal Health LLC |
Brenda Gerena |
| K212112 |
11/18/2021 |
Cardiologs Holter Platform |
Cardiologs Technologies |
Arezou Azar |
| K201782 |
01/22/2021 |
NuFace Trinity Plus Device |
Carol Cole Company dba NuFACE |
Danielle Barker Fernandes |
| K210009 |
11/24/2021 |
Guiding Catheter |
CenterPoint Systems LLC |
Marybeth Gamber |
| K201993 |
01/29/2021 |
E-connect S Endo Motor with built-in Apex Locator |
Changzhou Sifary Medical Technology Co., Ltd. |
Amanda Zhu |
| K211326 |
11/19/2021 |
EndoScreener |
Chengdu Wision Medical Device Co., LTD. |
JingJia Liu |
| K212013 |
11/10/2021 |
eKuore Pro 4T - REF EP0098 |
Chip Ideas Electronics S.L. |
Bernardo Plaza Trillo |
| K203561 |
01/04/2021 |
ChoiceSpine Navigation System |
ChoiceSpine, LLC |
Kim Finch |
| K210785 |
11/13/2021 |
Disposable Surgical Gowns |
Chongqing Litai Fashion Group Limited Company |
David Ni |
| K203526 |
01/12/2021 |
C Scope Visualization System |
CIT Ortho |
Megan Lecavalier |
| K213436 |
11/15/2021 |
Clarius Ultrasound Scanner |
Clarius Mobile Health Corp. |
Agatha Szeliga |
| K202857 |
01/05/2021 |
ClearPath Aligner |
ClearPath Orthodontics Ltd |
Waqas Wahab |
| K202575 |
01/22/2021 |
ClearPoint Array System |
ClearPoint Neuro, Inc. |
Pete Piferi |
| K200717 |
01/09/2021 |
CLEWICU System (ClewICUServer and ClewICUnitor) |
CLEW Medical Ltd. |
Avigdor Faians |
| K212444 |
11/17/2021 |
Qora Stool Management Kit |
CM Technologies, Inc. |
Nishith Chasmawala |
| K213389 |
11/10/2021 |
Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System |
Conformis Inc. |
Kara Johnson |
| K213455 |
11/24/2021 |
ControlRad Select Model Z |
ControlRad, Inc. |
Chris Fair |
| K202858 |
01/22/2021 |
Flex-ThreadTM Distal Fibula Intramedullary Nail System |
Conventus Orthopaedics, LLC |
Amanda Pentecost |
| K211517 |
11/09/2021 |
Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1 |
Convergent Laser Technologies |
Jennifer Mok |
| K210831 |
11/19/2021 |
OnQ Neuro |
CorTechs Labs, Inc |
Kora Marinkovic |
| K202507 |
01/21/2021 |
EEA Circular Stapler with Tri-Staple Technology |
Covidien |
Leo Chen |
| K202874 |
01/09/2021 |
Puritan Bennett Cuff Pressure Manager |
Covidien llc |
Jenny Liu |
| K212301 |
11/15/2021 |
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device |
Covidien, LLC |
Celso Duran |
| K212532 |
11/11/2021 |
Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) |
CRDLight Optoelectronic Technology Co., Ltd |
Fishy Liang |
| K200298 |
01/05/2021 |
ABI Instrument, Creo Electrosurgical System |
Creo Medical Ltd. |
Patrick Burn |
| K212510 |
11/04/2021 |
7 Series Phototherapy Device |
Daavlin Distributing Co. |
Michele Thiel |
| K210384 |
11/04/2021 |
CARESCAPE R860 |
Datex-Ohmeda, Inc. |
Trishia Mercier |
| K211289 |
11/09/2021 |
RMU-2000 Automated Chest Compression System |
Defibtech, LLC |
Allison Bohren |
| K202629 |
01/20/2021 |
Dentsply Sirona Universal Spray Glazes |
Dentsply Sirona |
Karl Nittinger |
| K213449 |
11/15/2021 |
DS Implants abutments provided with the EV connection |
Dentsply Sirona |
Courtney Clark |
| K202769 |
01/14/2021 |
VELYSÖ Robotic-Assisted Solution |
DePuy Ireland UC |
Erin Combs |
| K191878 |
01/29/2021 |
DEX Device |
Dex Surgical |
Guillaume Noury |
| K212529 |
11/23/2021 |
Hypotension Decision Assist Model HDA-OR2 |
Directed Systems Ltd |
Mark S. Leaning |
| K211894 |
11/24/2021 |
Trachealator |
DISA Medinotec |
Michelle Nieuwoudt |
| K202087 |
11/18/2021 |
DIXI Medical Microdeep Micro-Macro Depth Electrodes |
Dixi Medical |
Lucie Petegnief |
| DEN200040 |
11/03/2021 |
OMNIgene GUT Dx |
DNA Genotek Inc. |
Austin Udocor |
| K212171 |
11/01/2021 |
Electronic Blood Pressure Monitor |
Dongguan Kangweile Electronic Technology Co., Ltd. |
Zhixin Gao |
| K211967 |
11/09/2021 |
Sensual Massage, Ultra Pure |
Dreambrands, Inc. |
Cecile Kehoe |
| K213326 |
11/02/2021 |
VisionX 3.0 |
Durr Dental SE |
Oliver Lange |
| K211971 |
11/05/2021 |
Drug Relief v1 |
DyAnsys, Inc. |
Srini Nageshwar |
| K193608 |
01/15/2021 |
EBERLE Shaver System C3 and Accessories |
Eberle GmbH & Co. KG |
Udo Schniebs |
| K212558 |
11/24/2021 |
MicroPen EVO |
Eclipse Medcorp LLC |
Julie Summerville |
| K202856 |
01/25/2021 |
Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, A |
Edan Instruments, Inc. |
Ying Dai |
| K202336 |
01/23/2021 |
Patient Monitor |
Edan Instruments, Inc. |
Alice Yang |
| K202892 |
01/28/2021 |
Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s |
Edan Instruments, Inc. |
Alice Yang |
| K203131 |
01/22/2021 |
EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform |
Edwards Lifesciences, LLC |
Christine Chun |
| K212306 |
11/02/2021 |
Tapestry Biointegrative Implant |
Embody, Inc. |
Brianna Schehr |
| K192933 |
01/13/2021 |
Polyisoprene Powder Free, Black Colour Surgical Gloves |
Emerson & Co. Srl |
Laura Figliomeni |
| K212853 |
11/05/2021 |
Cervical Stand-Alone System |
Eminent Spine, LLC |
Stephen Courtney |
| K190677 |
01/29/2021 |
EndoClot |
EndoClot Plus Co., Ltd. |
Huihui Xie |
| K212823 |
11/01/2021 |
DePuy CONDUIT LLIF Angled Inserters |
Enztec Limited |
Claire Mai |
| K212595 |
11/12/2021 |
Erchonia FX-405 |
Erchonia Corporation |
Steven Shanks |
| K202754 |
01/28/2021 |
MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU |
eResearchTechnology GmbH |
Margit Kohlen |
| K201066 |
01/22/2021 |
ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length |
Ethicon Endo-Surgery, LLC |
Nathan Anderson |
| K201696 |
01/22/2021 |
ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length |
Ethicon Endo-Surgery, LLC |
Nathan Anderson |
| K211871 |
11/18/2021 |
FAICO Dental Implant System and CAD/CAM Abutments |
Faico Medical LLC |
Hernan Dario Fernandez |
| K202024 |
11/30/2021 |
ARROW Short Stem Humeral System |
FH Industrie |
Patricia Donnard |
| K212762 |
11/29/2021 |
geko W-2 |
Firstkind Limited |
Neil Buckley |
| K212169 |
11/23/2021 |
Air compression therapy system FO3002 |
Foshan Hongfeng Co., Ltd. |
Dongfeng Cheng |
| K212104 |
11/18/2021 |
Water-soluble Personal Lubricant |
Foshan PingChuang Medical Technology Co., Ltd. |
Huang Zhiyue |
| K212485 |
11/05/2021 |
Disposable Nitrile Examination gloves |
Fujian Yuanxin Safety Protection Technology Co., Ltd. |
Alan Wu |
| K212956 |
11/08/2021 |
FDR Cross (DR-XD 3000) |
FUJIFILM Corporation |
Randy Vader |
| K202878 |
01/29/2021 |
Prase-AP Anterior Cervical Plate System |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K203677 |
01/15/2021 |
ViewPoint 6 |
GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC |
Tracey Ortiz |
| K203114 |
01/08/2021 |
LOGIQ P10, LOGIQ P9, LOGIQ P8 |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Bryan Behn |
| K202505 |
01/11/2021 |
GetSet Surgical GoPLF! Posterior Lateral Fusion System |
GetSet Surgical, SA |
Ole Stoklund |
| K213041 |
11/18/2021 |
IPL Hair Removal, Model: OBT-02 |
Glan Electronics Co., Ltd. |
Lisa Pan |
| K203153 |
01/19/2021 |
CREO Stabilization System, Navigation Instruments, ExcelsiusGPS |
Globus Medical Inc. |
Jennifer Antonacci |
| K211998 |
11/18/2021 |
Desnuda Reflect |
Good Clean Love, Inc. |
Wendy Strgar |
| K212000 |
11/18/2021 |
Medley |
Good Clean Love, Inc. |
Wendy Strgar |
| K212506 |
11/07/2021 |
Medical Examination Gloves (Tested for Use with Chemotherapy) |
GUANGDONG GYMDA MEDICAL TECHNOLOGY CO.,LTD |
Olivia Chen |
| K202107 |
01/15/2021 |
Medical Protective Mask |
Guangdong Kingfa Sci.&Tech.Co., Ltd. |
Yu Xiaoge |
| K210222 |
11/02/2021 |
Disposable Medical Mask |
Guangdong Lide Medical Technology Co., Ltd. |
Zhuang Shenglin |
| K202110 |
11/05/2021 |
MStim Drop Model: LGT-233 |
Guangzhou Longest Science & Technology CO., Ltd. |
Xiaobing Luo |
| K202671 |
11/12/2021 |
DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) |
Guangzhou Xinbo Electronic Co., Ltd. |
Sammy Li |
| K212948 |
11/01/2021 |
Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I) |
Guangzhou Xinbo Electronic Co., Ltd. |
Sammy Li |
| K212460 |
11/05/2021 |
Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm╫9.5cm)) |
Guangzhou ZhengKang Medical Equipment Co.,Ltd |
Mike Wu |
| K213497 |
11/15/2021 |
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) |
H&abyz Co., Ltd. |
Hyunook (David) Han |
| K212471 |
11/04/2021 |
Medical Face Mask |
Haian Medigauze Co., Ltd |
Weihua Xu |
| K202314 |
01/13/2021 |
Procedure face mask (Model: KKF-2A) |
Han Zhaoqing Sporting Goods Company Limited |
Zhang Ming |
| K211744 |
11/24/2021 |
Non-Contact Infrared Thermometer, model HL710H |
Health & Life Co., Ltd |
Simon Lee |
| K203329 |
01/08/2021 |
HeartFlow Analysis |
HeartFlow, Inc. |
Windi Hary |
| K211817 |
11/05/2021 |
Anterion |
Heidelberg Engineering GmbH |
Arianna Schoess Vargas |
| K202842 |
11/26/2021 |
Medical surgical mask |
Henan Huibo Medical Co.,Ltd. |
Hui Lu |
| K200159 |
01/05/2021 |
Non-contact Infrared Body Thermometer, model:HTD8823US |
HeTaiDa Technology Co., Ltd. |
Tom Chen |
| K203142 |
01/15/2021 |
Veuron-Brain-pAb |
Heuron Co., Ltd. |
Dong Hoon Shin |
| K210383 |
11/12/2021 |
Wrap Accessory Electrodes |
Hi-Dow International Inc. |
Eric Chen |
| K212575 |
11/14/2021 |
Surgical Face Mask |
Hubei Huanfu Plastic Products Co., Ltd |
Yan Zhao |
| K201016 |
01/28/2021 |
LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) |
Huizhou Foryou Medical Devices Co., Ltd. |
Guosheng Tan |
| K211165 |
11/09/2021 |
Medical Face Masks, Model Name:MY020003 |
Huizhou Jie Bai Purification Co.,Ltd. |
Terrance Huang |
| K202358 |
01/29/2021 |
Protective Face Mask for Medical Use |
Hunan Heng Chang Pharmaceutical Co., Ltd. |
Tao Jingfeng |
| K212550 |
11/08/2021 |
Hura CTP v1.0 |
Hura Imaging, Inc. |
Danny Wang |
| K202414 |
01/07/2021 |
BrainInsight |
Hyperfine Research, Inc |
Robert Fasciano |
| K212456 |
11/17/2021 |
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System |
Hyperfine, Inc. |
Christine Kupchick |
| K202445 |
11/23/2021 |
Hystero-V Hysteroscope |
Hysterovue, Inc. |
Thomas Lawson |
| K212523 |
11/05/2021 |
VFSS Pro Mobile Digital Imaging System |
IMAGExRAY, LLC |
Gary Korkola |
| K210473 |
11/02/2021 |
Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) |
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. |
Hⁿsamettin Sonmez |
| K192913 |
01/19/2021 |
R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose |
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. |
Muhammed Hulusi Sonmez |
| K203748 |
11/29/2021 |
SeptiCyte RAPID |
Immunexpress, Inc |
LaKesha Hunt-Dickens |
| K212046 |
11/18/2021 |
Impertech Surgical Face Mask |
Impertech Industries Ltd. |
Mohamad Khweis |
| K201553 |
01/22/2021 |
Simply Iconic Implants |
Implant Direct Sybron Manufacturing, LLC |
Reina Choi |
| K202524 |
01/28/2021 |
Standard Sterilizable Tray |
Implant Direct Sybron Manufacturing, LLC |
Reina Choi |
| K203341 |
01/08/2021 |
ACS LD Uni FB Knee System |
Implantcast GmbH |
Juliane Hoeppner |
| K210543 |
11/03/2021 |
IM007 |
Implicity, Inc. |
David Perlmutter |
| K212487 |
11/18/2021 |
CoLink Vallux Plating System |
In2Bones USA, LLC |
Christine Scifert |
| K200560 |
01/06/2021 |
InBody |
InBody Co. Ltd. |
Koeun Jung |
| K203105 |
01/13/2021 |
Inion CompressOn Screw |
Inion Oy |
Kati Marttinen |
| K212467 |
11/04/2021 |
Disposable Nitrile Examination Glove |
Inner Mongolia Boming Medical Supplies Co., Ltd. |
Guo Hua |
| K212661 |
11/19/2021 |
Disposable Nitrile Examination Glove |
Inner Mongolia Cureguard Medical Technology Co.,Ltd. |
Guo Hua |
| K211662 |
11/18/2021 |
Reprocessed IntellaMap Orion High Resolution Mapping Catheter |
Innovative Health, LLC. |
Rick Ferreira |
| K202970 |
01/29/2021 |
Ventway Sparrow |
Inovytech Medical Solutions Ltd. |
Dana Hofeller |
| K212150 |
11/23/2021 |
Exablate Prostate System |
Insightec, Inc |
Nadir Alikacem |
| K202544 |
01/07/2021 |
Instylla Delivery Kit |
Instylla, Inc. |
Jennifer Greer |
| K212107 |
11/10/2021 |
Reverso |
Intelis Instruments Ltd. |
Amit Goren |
| K211876 |
11/12/2021 |
Intellijoint VIEW |
Intellijoint Surgical Inc. |
Katarina Jugovic |
| K212101 |
11/23/2021 |
da Vinci SP Firefly Imaging System |
Intuitive Surgical, Inc. |
Connor McCarty |
| K213089 |
11/10/2021 |
Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector |
Ivenix, Inc. |
John Sokolowski |
| K201685 |
01/19/2021 |
Potenza |
Jeisys Medical, Inc. |
Do Hyun Kim |
| K202577 |
01/11/2021 |
Medical Surgical Mask-Model MP002-5, MP002-6 |
Jiangmen Sure&Me Medical Product CO., LTD |
Liang Meixia |
| K212497 |
11/11/2021 |
Nitrile Examination Glove (Powder free, Blue) |
Jiangsu Jinlian Medical Technology Co., Ltd |
Wu Min |
| K211329 |
11/15/2021 |
Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle |
Jiangsu Kangbao Medical Equipment Co., Ltd |
Rujun Tang |
| K202640 |
01/22/2021 |
Surgical Mask |
Jiangsu Medpure Biological Technology Co., Ltd. |
Jianwen Fei |
| K212019 |
11/04/2021 |
Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Colle |
Jiangsu Micsafe Medical Technology Co., Ltd |
Tony Yang |
| K202491 |
01/06/2021 |
Disposable Surgical Face Mask |
Jiangsu NewValue Medical Products Co., Ltd. |
Zhou Zhengguo |
| K211937 |
11/18/2021 |
SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System |
Jiangsu Synecoun Medical Technology Co., Ltd. |
Zhheng Li |
| K202904 |
01/21/2021 |
Surgical Face Mask |
Jiangxi Feilikang Medical Technology Co., Ltd. |
Shijun Zhang |
| K202719 |
01/04/2021 |
Disposable Medical Face Masks |
Jiangxi Sanxin Medtec Co., Ltd. |
Shuiqing Sun |
| K202282 |
01/29/2021 |
Neodent Implant System - Zirconia Implant System |
JJGC Industria e Comercio de Materiais Dentarios SA |
Mariana Soares Hartmann |
| K202839 |
01/21/2021 |
Overlapped Compression Therapy |
JKH HEALTH CO., LTD. |
Pu Jiang |
| K203652 |
01/06/2021 |
Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740 |
JKH USA, LLC |
Bill Quanqin Dai |
| K210930 |
11/29/2021 |
ACUVUE« OASYS MAX 1-DAY Contact Lenses (senofilcon A) |
Johnson & Johnson Vision Care, Inc. |
Jamie Frenz-Ross |
| K200289 |
01/28/2021 |
Michler-Kapp Cardiovascular Vent Catheter |
Kapp Surgical Instrument, Inc. |
Nicole Merrifield |
| K212695 |
11/15/2021 |
KARL STORZ ICG Imaging System |
KARL STORZ Endoscopy America |
Mario Trujillo |
| K210854 |
11/16/2021 |
Enteral Feeding Set |
KB Medical (Group) Inc. |
Chunsheng Sheng |
| K212504 |
11/07/2021 |
Isolation Gown AAMI Level 3 |
Kenpax International Limited |
Solomon Chen |
| K201114 |
01/05/2021 |
Bidop 7 |
Koven Technology, Inc. |
Heather Bell |
| K211741 |
11/22/2021 |
Pre-Formed Extra Support Guidewire |
Lake Region Medical |
Deko Hussein |
| K212984 |
11/12/2021 |
MiPACS HTML5 Web Viewer |
LEAD Technologies Inc. |
William Little |
| K210432 |
11/03/2021 |
LELTEK Ultrasound Imaging System (Model: LU700 Series) |
Leltek Inc |
Jessie Wang |
| K212003 |
11/10/2021 |
ESSENZ Patient Monitor |
LivaNova Deutschland GmbH |
Florian Goetz |
| K202221 |
01/29/2021 |
VX650 |
Luneau Technology Operations |
Yossi Constantinis |
| K211733 |
11/10/2021 |
Lunit INSIGHT CXR Triage |
Lunit Inc. |
Seulhee Jung |
| K211678 |
11/17/2021 |
Lunit INSIGHT MMG |
Lunit Inc. |
Joohee Lee |
| K212607 |
11/15/2021 |
Darwin |
Luvo Medical Technologies, Inc |
Gregory Berzak |
| K211586 |
11/01/2021 |
Nitrile Examination Gloves (Blue, Violet) |
Lyncmed Medical Technology (Beijing) Co., Ltd. |
Jiali Zhou |
| K213251 |
11/18/2021 |
HANAROSTENT Esophagus Asymmetric (CCC) |
M.I.Tech Co., Ltd. |
Sunyoung Jo |
| K213090 |
11/19/2021 |
Frontier Series Power Wheelchairs |
Magic Mobility |
Jill Mckechnie |
| K203840 |
01/28/2021 |
BOSS 8F Balloon Guide Catheter |
Marblehead Medical LLC |
Kristin M. Mortenson |
| K200918 |
01/07/2021 |
SurgiWrap FROST |
MAST Biosurgery |
Roel Trip |
| K213070 |
11/18/2021 |
MD-320W Ultrasound Biomicroscope |
Meda Co., LTD |
Linda Zhang |
| K213071 |
11/16/2021 |
MOTOTM Partial Knee & MOTO PFJ Systems Extension |
Medacta International S.A. |
Stefano Baj |
| K201471 |
01/11/2021 |
M-Vizion Femoral Revision System Extension |
Medacta International SA |
Stefano Baj |
| K203482 |
01/26/2021 |
M.U.S.T. Pedicle Screw Extension and Long Tab Implants |
Medacta International SA |
Stefano Baj |
| K203671 |
01/13/2021 |
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System |
Medacta International SA |
Stefano Baj |
| K203485 |
01/19/2021 |
SnugFit All-Suture Anchor |
Medacta International SA |
Stefano Baj |
| K210859 |
11/05/2021 |
NextARÖ Spine Platform |
Medacta International, SA |
Stefano Baj |
| K193266 |
01/22/2021 |
MIIN |
Medico USA Inc. |
Peter Son |
| K203381 |
01/15/2021 |
Dynanail Mini Hybrid |
MedShape Inc |
Akhilesh Gokhale |
| K201577 |
01/07/2021 |
MatriDerm |
MedSkin Solutions Dr. Suwelack AG |
Zuzana Hⁿlsbusch |
| K203639 |
01/13/2021 |
StealthStation Cranial Software v1.3.2 |
Medtronic Navigation, Inc. |
Taylor Gold West |
| K213454 |
11/23/2021 |
Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm |
Medtronic Powered Surgical Solutions |
Carrie Eddings |
| K212653 |
11/19/2021 |
Catalyft LS Expandable Interbody System |
Medtronic Sofamor Danek USA, Inc. |
Madhuvanthi Soundirarajan |
| K203678 |
01/15/2021 |
CD HORIZONÖ Spinal System |
Medtronic Sofamor Danek USA, INC. |
Madhuvanthi Soundirarajan |
| K203104 |
01/26/2021 |
IBM iConnect Access |
Merge Healthcare Incorporated |
Carol Nakagawa |
| K212839 |
11/16/2021 |
Opulent TiNbN Coated Knee |
Meril Healthcare Pvt. Ltd. |
Neelam Desai |
| K212199 |
11/03/2021 |
ASAP Aspiration Catheter, ASAPLP Aspiration Catheter |
Merit Medical Systems, Inc. |
Kirk McIntosh |
| K211463 |
11/24/2021 |
Regulora |
metaMe Health, Inc. |
Tim Rudolphi |
| K202333 |
01/14/2021 |
Lockado Repositionable Hemostasis Clip |
Micro-Tech (Nanjing) Co., Ltd. |
Sally He |
| K211288 |
11/04/2021 |
Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B |
Microlife Intellectual Property GmbH |
Gerhard Firck |
| K193079 |
01/11/2021 |
ICE COMPRESSION FIRST, DUO, & MOOVE Systems |
mks paris |
Cervilla Stanislas |
| K211356 |
11/08/2021 |
GIQuant |
Motilent Ltd |
Ian Knott |
| K192650 |
01/29/2021 |
i_Space 1.5T Superconducting Magnetic Resonance Imaging System |
MRI Division, Beijing Wandong Medical Technology Co., Ltd. |
Zhou Lu |
| K210969 |
11/03/2021 |
Nulife |
MRK Healthcare Pvt Ltd |
Anil R Dave |
| K213184 |
11/23/2021 |
MZ Skin LightMAX Supercharged LED Mask 2.0 |
Mz Skin |
Maryam Zamani |
| K211295 |
11/24/2021 |
Surgical Mask (sterile) |
Nanjing 3H Medical Products Co., Ltd. |
Chun Yang |
| K212264 |
11/13/2021 |
Surgical Face mask |
Nantong Taiweishi Medical Technology Co., Ltd. |
Zhang Xuewen |
| K201930 |
01/17/2021 |
Nanum Syringe |
Nanum Company Co., Ltd |
Jeong Ung Jong |
| K203339 |
01/06/2021 |
NEOLab Clear Aligners |
New England Ortho Lab, Inc |
Christian Saurman |
| K213214 |
11/24/2021 |
Xpert Wrist |
Newclip Technics |
Gregoire Larche |
| K212640 |
11/18/2021 |
Stratum« Ankle Fusion Plating System |
Nextremity Solutions, Inc. |
Elise Fox |
| K200429 |
01/29/2021 |
BEE Cages |
NGMedical GmbH |
Stella Hahn |
| K212446 |
11/03/2021 |
NuVasive Anterior Cervical Plate Systems |
NuVasive, Incorporated |
Priscila Saraiva |
| K203201 |
01/12/2021 |
NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fu |
NuVasive, Incorporated |
Sali Gully |
| K211650 |
11/24/2021 |
The Radian MIS Bunion System |
Nvision Biomedical Technologies, Inc |
Diana Langham |
| K213421 |
11/19/2021 |
Vector« Hammertoe Correction System |
Nvision Biomedical Technologies, Inc |
Diana Langham |
| K211063 |
11/19/2021 |
HALYARD Flexaprene Green Powder-Free Exam Glove |
O & M Halyard, Inc. |
Steven Dowdley |
| K202622 |
01/07/2021 |
Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate |
O & M Halyard, Inc. |
Steven Dowdley |
| K201300 |
01/26/2021 |
Airway Mobilescope |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K201758 |
01/21/2021 |
EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K212336 |
11/17/2021 |
Soteria.AI |
Omega Medical Imaging, LLC |
John Newman |
| K203241 |
01/14/2021 |
OmniGuide BeamPath OTO-U Fiber |
OmniGuide, Inc. |
David Johnson |
| K212664 |
11/30/2021 |
Sherlock |
Open Implants, LLC |
Gregg Gellman |
| K200609 |
01/13/2021 |
ENTity WiFi Video Nasopharyngoscope System |
Optim, LLC |
Jenna Lipka |
| K212496 |
11/04/2021 |
Ortho Aligner System |
Ortho Lab Services, LLC |
Zuzana Huelsbusch |
| K212731 |
11/15/2021 |
Circul8 Pro |
Ortho8 Inc. |
Nordeen Taylor |
| K201241 |
01/11/2021 |
Striate+Ö |
Orthocell Ltd |
Alison Carleton |
| K202363 |
01/19/2021 |
HBP7 Settable Hemostatic Bone Putty |
Orthocon, Inc. |
Howard Schrayer |
| K212044 |
11/05/2021 |
TrueLok Evo |
Orthofix SRL |
Gianluca Ricadona |
| K201838 |
01/29/2021 |
PediFlex Flexible Nail System |
OrthoPediatrics Corp. |
Yan Li |
| K202810 |
01/06/2021 |
AutoStrut G2 |
OrthoSpin Ltd |
Oren Cohen |
| K203465 |
01/06/2021 |
OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design |
OSSIO Ltd. |
Taly Lindner |
| K201187 |
01/23/2021 |
Cytoplast Titanium-Reinforced PTFE Membranes |
Osteogenics Biomedical, Inc. |
Shane Shuttlesworth |
| K210921 |
11/02/2021 |
TaiChiB |
Our United Corporation |
Qi Liu |
| K210782 |
11/26/2021 |
Tablo Cartridge |
Outset Medical, Inc. |
Jennifer Mascioli-Tudor |
| K203658 |
01/12/2021 |
Micro C Medical Imaging System, M01 |
OXOS Medical, Inc. |
Evan Ruff |
| K211286 |
11/16/2021 |
Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger |
Pall Corporation |
Brian Goetz |
| K210117 |
11/30/2021 |
Paltop Narrow Implant |
Paltop Advanced Dental Solutions, Ltd |
Zina Gurgov |
| K211315 |
11/09/2021 |
Comby EEG Caps |
Pamel d.o.o |
Marko Pavic |
| K212895 |
11/08/2021 |
Paragon 28 External Ring Fixation System |
Paragon 28, Inc |
Haylie Hertz |
| K202019 |
01/14/2021 |
Maven Patient-Specific Instrumentation |
Paragon 28, Inc. |
Haylie Hertz |
| K212814 |
11/29/2021 |
C2 CryoBalloon Ablation System |
PENTAX of America, Inc. |
William Goeller |
| K211345 |
11/24/2021 |
C-30 Crown Kit |
Perfect Fit Crowns, LLC |
Steve Ziskind |
| K203280 |
01/12/2021 |
Hepatica v1 (Hepatica v1.0.0) |
Perspectum Ltd. |
Jaco Jacobs |
| K211432 |
11/23/2021 |
Myomics Q |
Phantomics Inc. |
Sangmin Cho |
| K211168 |
11/22/2021 |
Philips Incisive CT on Trailer |
Philips Healthcare (Suzhou) Co., Ltd. |
Shiguang An |
| K212673 |
11/19/2021 |
MR 5300 |
Philips Medical Systems Nederland B.V. |
Jan van de Kerkhof |
| K203231 |
01/11/2021 |
Switched Internal Paddles |
Philips North America LLC |
Neha Hardiya |
| K200037 |
01/22/2021 |
Piccolo Medical SmartPICC System |
Piccolo Medical, Inc |
Alexey Salamini |
| K200731 |
01/21/2021 |
pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 |
pjur group Luxembourg SA |
Andrea Giebel |
| K212937 |
11/04/2021 |
Dakota ALIF Plate System |
Precision Spine, Inc. |
Michael Dawson |
| K203129 |
01/12/2021 |
NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System |
Precision Spine, Inc. |
Michael Dawson |
| K210344 |
11/10/2021 |
inVisionOS |
PrecisionOS Technology Inc. |
Danny Goel |
| K202595 |
01/21/2021 |
Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask |
Premier Guard USA LLC |
Howard Sherman |
| K213425 |
11/17/2021 |
BruxZir Esthetic |
Prismatik Dentalcraft, Inc. |
So Hyun Park |
| K193273 |
01/05/2021 |
Insulin Syringe |
Promisemed Hangzhou Meditech Co., Ltd. |
Liqing Yang |
| K211890 |
11/17/2021 |
Promisemed Sharps container |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K201366 |
01/21/2021 |
Forwarts |
Pronova Laboratories BV |
Diede Klever |
| K203074 |
11/19/2021 |
Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) |
PT. Universal Gloves |
Li I-Feng |
| K213254 |
11/15/2021 |
Axialis Ophthalmic Ultrasound System |
Quantel Medical |
Bruno Pages |
| K202672 |
01/21/2021 |
Precision Delivery Infusion Set |
Quest Medical, Inc. |
Tosan Eweka |
| K211342 |
11/23/2021 |
Sofia 2 Campylobacter FIA |
Quidel Corporation |
Michelle Bodien |
| K203067 |
11/08/2021 |
Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F |
Qura S.r.l. |
Raffaella Tommasini |
| K201320 |
11/03/2021 |
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor |
Qura S.r.l. |
Raffaella Tommasini |
| K203308 |
01/15/2021 |
Ali Interbody Fusion System |
Raed M. Ali, M.D., Inc. |
Raed Ali |
| K213226 |
11/29/2021 |
RCT700 |
RAY Co., Ltd |
Youna Im |
| K202537 |
11/26/2021 |
ALTMS Magnetic Stimulation Therapy System |
REMED Co., Ltd |
Yonsoo Nam |
| K211206 |
11/09/2021 |
FreedomEdge(R) Syringe Infusion System |
Repro-Medical System, Inc., dba Koru Medical Systems |
Brian Schiller |
| K200565 |
01/17/2021 |
Galapogos |
ResMed Corp |
Rose Malonzo |
| K201897 |
01/15/2021 |
Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 |
Richard Wolf Medical Instruments Corporation |
Michael Loiterman |
| K203220 |
01/29/2021 |
cobas BKV |
Roche Molecular Systems, Inc. |
Raji Grewal |
| K202408 |
01/21/2021 |
cobas CTNG for use on cobas 6800/8800 systems |
Roche Molecular Systems, Inc. |
Aradhana Karthikeyan |
| K212331 |
11/09/2021 |
BodySculp |
Rohrer Aesthetics, LLC |
Mark Rohrer |
| K210990 |
11/22/2021 |
Non-sterile Powder Free Nitrile Examination Gloves |
Rubberex Alliance Sdn Bhd |
Sabri Abd Hamid |
| K212404 |
11/03/2021 |
S.I.N. Instrument Kits |
S.I.N. - Sistema de Implante Nacional S.A. |
Denise Domiciano |
| K211139 |
11/26/2021 |
CUBE Air Purifier |
Samsung Electronics Co., Ltd. |
Hana Jung |
| K203184 |
11/12/2021 |
HYDRASHIFT 2/4 isatuximab |
Sebia |
Karen Anderson |
| K212887 |
11/10/2021 |
RTapp |
SegAna, Inc. |
Jennifer Bosley |
| K202833 |
01/19/2021 |
Sequel External Fixation Device |
Sequel Medical Inc. |
Valentina Kamysheva |
| K212488 |
11/26/2021 |
Synthetic Nitrile Examination Gloves |
Shandong Hongxin Chemicals Co., Ltd. |
Ping Wang |
| K210777 |
11/02/2021 |
Powder Free Nitrile Patient Examination Gloves, Blue Color |
Shandong Jieshi Medical Products Co.,Ltd |
Li Biao |
| K210779 |
11/10/2021 |
Powder Free Nitrile Patient Examination Gloves, Blue Color |
Shandong Shangwei Medical Products Co.,Ltd |
Li Hua |
| K202594 |
01/06/2021 |
Medical Surgical Masks-Non Sterile |
Shandong T&F Nonwoven Co., LTD |
Minsheng Zhao |
| K211169 |
11/24/2021 |
Bronchoscope System |
Shanghai AnQing Medical Instrument CO., Ltd. |
Shuwen Fan |
| K211103 |
11/04/2021 |
Powder Free Vinyl Examination Gloves |
Shanghai Shengda Medical Applications Co., Ltd |
Ying Su |
| K193271 |
01/15/2021 |
uAI EasyTriage-Rib |
Shanghai United Imaging Intelligence Co., Ltd. |
Zhao Xiaojing |
| K202350 |
01/06/2021 |
SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System |
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) |
Flower Cai |
| K211562 |
11/23/2021 |
Virtue RF |
ShenB Co Ltd |
Sunny Kang |
| K202415 |
01/22/2021 |
VirtueRF |
ShenB Co Ltd |
Oskar Lee |
| K212897 |
11/04/2021 |
IPL Hair Removal Device, model: AI01 |
Shenzhen Century Dongyuan Technology Co Ltd. |
He Wang |
| K193386 |
01/27/2021 |
Wrist Electronic Sphygmomanometer |
Shenzhen Changkun Technology Co., Ltd. |
Steve Li |
| K193387 |
01/27/2021 |
Arm Electronic Sphygmomanometer |
ShenZhen Changkun Technology CO.,LTD. |
Steve Li |
| K201468 |
01/25/2021 |
Pulse Oximeter |
Shenzhen Creative Industry Co., Ltd. |
Jia Wang |
| K211055 |
11/05/2021 |
Microcurrent device (Model: HBR2-1) |
Shenzhen DJ Medical Equipment Co., Ltd. |
Jet Li |
| K212697 |
11/19/2021 |
Leaf Smooth |
Shenzhen Leaflife Technology Co., Ltd |
Cheng Qiang |
| K212084 |
11/03/2021 |
Fetal Doppler |
Shenzhen Mericonn Technology Co., Ltd. |
Jiang Chuanyuan |
| K202405 |
01/07/2021 |
BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1 |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Yanhong Bai |
| K212900 |
11/05/2021 |
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD. |
Shi Jufang |
| K212265 |
11/16/2021 |
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co.,LTD |
Hao Yixuan |
| K212989 |
11/22/2021 |
Low-frequency Stimulator (Model: AST-645, AST-646) |
Shenzhen OSTO Technology Co., Ltd. |
Li Yang |
| K203746 |
11/10/2021 |
Venen-trainer (Model: FM150, SFM90) |
Shenzhen Pango Electronic CO., LTD |
Guojun Zeng |
| K201579 |
01/15/2021 |
Infrared Thermometer |
Shenzhen Xunwei Industrial Co., Ltd. |
Liu Shengcai |
| K212223 |
11/24/2021 |
Atellica CH Enzymatic Creatinine_3 (ECre3) |
Siemens Healthcare Diagnostics Inc. |
Ian Thompson |
| K202826 |
01/15/2021 |
IMMULITE« 2000 Cortisol |
Siemens Healthcare Diagnostics Products Ltd. |
Malgorzata Robak |
| K203270 |
01/15/2021 |
IMMULITE/IMMULITE« 1000 Cortisol |
Siemens Healthcare Diagnostics Products Ltd. |
Malgorzata Robak |
| K203726 |
01/19/2021 |
ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter |
Siemens Medical Solutions USA, Inc. |
HyunJung Lee |
| K211726 |
11/05/2021 |
Acuson SC2000 Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
Christine Dunbar |
| K212621 |
11/12/2021 |
MAMMOVISTA B.smart |
Siemens Medical Solutions USA, Inc. |
Martin Rajchel |
| K203345 |
01/07/2021 |
MULTIX Impact |
Siemens Medical Solutions USA, Inc. |
Martin Rajchel |
| K203340 |
01/06/2021 |
MULTIX Impact C |
Siemens Medical Solutions USA, Inc. |
Martin Rajchel |
| K203327 |
01/25/2021 |
VERTACONNECT TLIF Cage |
SIGNUS Medizintechnik |
Antje Schmidt |
| K203405 |
01/27/2021 |
EVOS Large Fragment Plating System |
Smith & Nephew, Inc. |
Thomas Fearnley |
| K210833 |
11/26/2021 |
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula |
Smiths Medical ASD, Inc. |
Nancy DeAngelo |
| K202288 |
11/19/2021 |
Finebeam |
SNJ Co., Ltd. |
Hyang-Kee Lee |
| K211483 |
11/15/2021 |
SofWave System |
Sofwave Medical Ltd. |
Ruthie Amir |
| K202732 |
11/03/2021 |
SOL-CARE IV Bag Safety Connector |
Sol-Millennium Medical Group |
Jim Barley |
| K201801 |
01/29/2021 |
Rapid Acoustic Pulse Device |
Soliton Inc. |
Leslie Honda |
| K212502 |
11/05/2021 |
Resonic Rapid Acoustic Pulse Device |
Soliton Inc. |
Leslie Honda |
| K211387 |
11/23/2021 |
Breathe Easy Mobile Respiratory Monitor (MRM) |
Sound Life Sciences, Inc. |
Kamal Shah |
| K211845 |
11/16/2021 |
Deploy Expandable Interbody System |
Southern Spine LLC |
Calder Clay |
| K211651 |
11/22/2021 |
Eclipse PRO |
Spacelabs Healthcare Ltd. |
Roger Moldon |
| K201873 |
01/02/2021 |
Sparrow Therapy System |
Spark Biomedical, Inc. |
Daniel Powell |
| K213451 |
11/22/2021 |
Spartan MC 0165 |
Spartan Micro |
Gary Avedovech |
| K203506 |
01/15/2021 |
PERLA« TL posterior osteosynthesis system |
SPINEART |
Franck Pennesi |
| K212109 |
11/14/2021 |
Spin Care Disposable Protective Mask Level 3 |
SpinTech LLC |
Jim Jean |
| K202660 |
01/22/2021 |
SPRINT PNS System |
SPR Therapeutics, Inc. |
Kathryn Stager |
| K212448 |
11/12/2021 |
NightGuard Flex |
SprintRay Inc |
Sara Moghtadernejad |
| K212515 |
11/03/2021 |
MOVIX DReamy |
Stephanix |
Sandie Perret |
| K212338 |
11/01/2021 |
SterileRight sterilization pouch and roll |
SterileRight Packaging Mfg., Inc. |
Thomas Chou |
| K203223 |
01/28/2021 |
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide |
STERIS |
Marcia L. Benedict |
| K202104 |
01/14/2021 |
BioGuard EUS Air/Water and Suction Valves |
Steris Corporation |
Carroll Martin |
| K202721 |
01/08/2021 |
Celerity 20 Steam Biological Indicator for IUSS |
STERIS Corporation |
Anthony Piotrkowski |
| K211347 |
11/23/2021 |
Uretero1 Ureteroscope System |
STERIS Corporation |
Caroll Martin |
| K203630 |
01/08/2021 |
BioGuard Air/Water and Suction Valves |
STERIS Corporations |
Carroll Martin |
| K212633 |
11/24/2021 |
Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue |
String King Lacrosse, LLC |
Thomas Frasca |
| K212511 |
11/04/2021 |
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) |
Stryker |
Marlene Fraga |
| K212455 |
11/16/2021 |
InZone Detachment System |
Stryker Neurovascular |
Breskella Halteh |
| K211594 |
11/26/2021 |
Trevo Trak 21 Microcatheter |
Stryker Neurovascular |
Shivani H Patel |
| K210836 |
11/30/2021 |
InstruSafe Instrument Protection System |
Summitt Medical LLC |
Debra Kridner |
| K201418 |
01/29/2021 |
Sunset Heated CPAP Tube |
Sunset Healthcare Solutions, Inc. |
N. (Nazree) Williams |
| K212600 |
11/18/2021 |
Disposable Medical Nitrile Examination Gloves (Non-sterile) |
Suqian Linglian Medical Technology Co., Ltd |
Eric Li |
| K200384 |
01/28/2021 |
HipXpert 3D Display and Anchoring Application |
Surgical Planning Associates, Inc |
Stephen B Murphy |
| K212526 |
11/09/2021 |
Surgical Face Mask |
Suzhou JaneE Medical Technology Co., Ltd. |
Chen Ke |
| K212284 |
11/10/2021 |
Disposable Automatic Core Biopsy Instrument |
Suzhou Leapmed Healthcare Corporation |
Yu Zhu |
| K210042 |
11/17/2021 |
Disposable Surgical Mask |
Suzhou Letian Protective Products Co., Ltd. |
Huang Qizhi |
| K203372 |
11/03/2021 |
SyMRI |
SyntheticMR AB |
Lisa Warnroth |
| K212029 |
11/16/2021 |
Disposable Medical Nitrile Examination Gloves (non-sterile) |
Taizhou Kangjian Medical Equipments Co., Ltd. |
Hua Cong |
| K200091 |
11/18/2021 |
Capiox iCP Centrifugal Pump |
Terumo Cardiovascular Systems Corporation |
John Chesney |
| K213406 |
11/18/2021 |
Savvy Mask - Level 3 Surgical Face Mask |
Texas MedPlast LLC |
Diego Olmos |
| K210095 |
11/23/2021 |
Playboy Premium Silicone Lubricant |
Thai Nippon Rubber Industry Public Company Limited |
Ryosuke Takamiya |
| K212151 |
11/03/2021 |
FLUME catheter |
The Flume Catheter Company, Ltd. |
Roger Holmes |
| K201719 |
01/14/2021 |
Vital Sleep |
The Snore Reliever Company, LLC |
David Hernandez |
| K203181 |
01/22/2021 |
Nerivio, FGD000075-4.7 |
Theranica Bioelectronics ltd |
Alon Ironi |
| K202700 |
01/14/2021 |
ART-Plan |
TheraPanacea |
Edwin Lindsay |
| K211541 |
11/26/2021 |
MammoScreen 2.0 |
Therapixel |
Quentin De Snoeck |
| K210628 |
11/04/2021 |
X-FLO Fluid Management System |
Thermedx, LLC |
Daniel Marijian |
| K200999 |
01/06/2021 |
Thermidas IR System (ThIR-A615) |
Thermidas Americas, Inc. |
Karo Kujanpaa |
| K201014 |
01/13/2021 |
MyOnyx System |
Thought Technology LTD. |
Zena Butris |
| K202319 |
11/12/2021 |
Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) |
Tianjin Huahong Technology Co., Ltd. |
Yan Li |
| K201625 |
01/12/2021 |
Disposable Medical Surgical Mask |
Tianjin Saiyuan Technology CO., LTD |
Hong Cai |
| K211359 |
11/12/2021 |
Tornier PerformÖ Patient-Matched Primary Reversed Glenoid and BLUEPRINTÖ Patient Specific Instrumentation |
Tornier, Inc. |
Lisa Stahl |
| K211199 |
11/08/2021 |
ST AIA-PACK BNP Assay |
Tosoh Bioscience, Inc. |
Louise Musante |
| K201922 |
01/14/2021 |
Trophikos Vaginal Moisturizer |
Trophikos, LLC |
Terri Jackson Wade |
| K210573 |
11/19/2021 |
Velofix SA Cervical Cage |
U&I Corporation |
Jee-Ae Bang |
| K203747 |
01/25/2021 |
Non-Contact Forehead Thermometer (Models UT306H & UT308H) |
Uni-Trend Technology (China) Co., Ltd. |
Mike Mao |
| K203656 |
01/22/2021 |
Non-Contact Forehead Thermometer (UT30H) |
Uni-Trend Technology(CHINA) CO.,LTD |
Mike Mao |
| K211577 |
11/05/2021 |
SoftFix Balloon Trocar |
Unimax Medical Systems Inc. |
Monoj Mon Kalita |
| K201608 |
01/28/2021 |
GenesisZr UHT700 Zirconia |
United Dental Resources Corporation |
John Von Thaden |
| K201650 |
01/15/2021 |
VMCore Biopsy Needle |
URO-1, Inc. |
Thomas Lawson |
| K211032 |
11/19/2021 |
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr |
UroGen Pharma Ltd |
James G. Otinger |
| K203669 |
01/14/2021 |
Mobius3D |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K203803 |
01/26/2021 |
VASOBand Vascular Compression Device |
VASOInnovations, Inc |
Rajendra Gurudas Sardesai |
| K203797 |
01/25/2021 |
vatech A9 (Model : PHT-30CSS) |
Vatech Co., Ltd |
Daniel Kim |
| K211546 |
11/09/2021 |
Vektor Computational ECG Mapping System (vMap) |
Vektor Medical, Inc. |
Mike Monko |
| K211947 |
11/03/2021 |
GlideScope BFlex 2.8 Single-Use Bronchoscope |
Verathon Medical (Canada) ULC |
Teresa Davidson |
| K201085 |
01/15/2021 |
NeVa PV Thrombectomy Device |
Vesalio |
Gustavo Prado |
| K203117 |
01/07/2021 |
TissueTak device |
Via Surgical Ltd. |
Ofek Levin |
| K202742 |
01/25/2021 |
Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory |
Viasonix Ltd. |
Dan Manor |
| DEN210012 |
11/23/2021 |
vPatch |
Virility Medical |
Bosmat Friedman |
| K201411 |
01/29/2021 |
Visage Breast Density |
Visage Imaging GmbH |
Stefan Strowich |
| K212896 |
11/05/2021 |
Visible Patient Suite |
Visible Patient, SAS |
Emeline Degivry |
| K212583 |
11/10/2021 |
AlignRT Plus |
Vision RT Ltd |
Jade Dunphy |
| K210265 |
11/22/2021 |
VS3 Iridium Sytem |
Visionsense Ltd. |
Nancy Sauer |
| K211854 |
11/22/2021 |
VITA Akzent LC |
VITA Zahnfabrik GmbH H Rauter & Co |
Bernd Walker |
| K203719 |
01/19/2021 |
IntraSight Mobile |
Volcano Corporation |
Linda Schulz |
| K201082 |
11/10/2021 |
LTV2 Series Ventilators |
Vyaire Medical Inc |
Colleen Watson |
| K202694 |
01/14/2021 |
Vycor Medical Viewsite Brain Access System (ôVBASö) and VBAS with Alignment Clip (ôVBAS ACö) (together the ôVBAS Familyö) |
Vycor Medical INC. |
Theo Novak |
| K212992 |
11/18/2021 |
LINK« Embrace Shoulder System - Reverse Configuration |
Waldemar Link GmbH & Co. KG |
Stefanie Fuchs |
| K211697 |
11/16/2021 |
Esperance Aspiration Catheter System |
Wallaby Medical |
Nathaniel Knock |
| K202653 |
01/15/2021 |
Gymform Total ABS |
Well Brain International Ltd. |
Victor K. Wai |
| K213000 |
11/15/2021 |
Air Compression Massager (Model LF-FT003) |
Wenzhou Lingfeng Electronic Technology Co., Ltd |
Xiaoqun Ye |
| K213383 |
11/09/2021 |
WHILL Model C2 |
Whill, Inc. |
Tsuyoshi Iriyama |
| K202310 |
01/29/2021 |
Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back |
Wildcat PPE, LLC |
Matthew McFarlane |
| K200769 |
01/06/2021 |
Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B |
Wilson Instruments (SHA) Co., LTD |
Juan Wu |
| K201259 |
01/08/2021 |
ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System |
Wright Medical Technology, Inc. |
Anna Hinton |
| K212996 |
11/16/2021 |
Sterile PHALINX Hammertoe System |
Wright Medical Technology, Inc. |
Michael Mullins |
| K212787 |
11/08/2021 |
GT5 conductive & abrasive gel |
Wuhan Greentek Pty Ltd. |
Yarong Liu |
| K212722 |
11/26/2021 |
Nitrile Examination Gloves |
Wuhan Huirui Technology Co., Ltd |
Jing Li |
| K212344 |
11/16/2021 |
Surgical Mask |
Xiantao Dingcheng Non-woven Product Co., Ltd |
Cheng Qin |
| K202017 |
01/08/2021 |
Passion Natural Water Based Lubricant |
XR LLC |
Louie Goryoka |
| K202291 |
01/08/2021 |
Button Loop |
Yunyi (Beijing) Medical Device Co., Ltd. |
Xiaowei Liu |
| K202398 |
01/29/2021 |
Ti3Z Cervical Interbody System |
Zavation Medical Products, LLC |
Katie Motley |
| K212707 |
11/05/2021 |
CoolSculpting Elite System |
Zeltiq Aesthetics, Inc. |
Vicky Chai |
| K202676 |
11/05/2021 |
Disposable Medical Face Mask |
Zhejiang Senhong Medical&Instrument Co., Ltd. |
Eric Jian |
| K201582 |
01/15/2021 |
Non-contact Electronic Forehead Infrared Thermometer |
Zhongshan Jinli Electronic Weighingá Equipment Co., Ltd. |
Jerry Liang |
| K203507 |
01/28/2021 |
Vitality« Spinal Fixation System |
Zimmer Biomet Spine, Inc. |
Alex Pawlowski |
| K212259 |
11/12/2021 |
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank |
Zirdent New Material Co., Ltd |
Jia Li |
| K202488 |
01/07/2021 |
ZSFab Cervical Interbody System |
ZSFab Inc. |
Kai Xu |
